Therapeutic agent for inhalation pneumonia, pulmonary suppuration or pulmonary abscess

Abstract

The invention relates to a therapeutic agent for inhalation pneumonia, pulmonary suppuration or pulmonary abscess. [Problem] The present invention relates to a safer and more effective therapeutic agent for respiratory tract infections. [Solution] A therapeutic agent for inhalation pneumonia, pulmonary suppuration or pulmonary abscess, said agent containing, as an active ingredient, 7-[(3S, 4S)-3-{(cyclopropylamino) methyl}-4-fluoropyrrolidin-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1, 4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable salt thereof.

Description

[0001] This application is a divisional application of the application with application number "201880039674.9" and invention title "Therapeutic agent for aspiration pneumonia, pulmonary suppuration or pulmonary abscess". Technical Field

[0002] This invention relates to therapeutic agents for aspiration pneumonia, lung suppuration, or lung abscess. Background Technology

[0003] Since the development of norfloxacin, quinolone carboxylic acid antibacterial agents known as new quinolones have been developed worldwide, and many of these new quinolone antibacterial agents are now widely used as treatments for infectious diseases.

[0004] Meanwhile, the applicant has already disclosed quinolone carboxylic acid derivatives represented by general formula (1) (Patent Document 1).

[0005] [Formula 1] In equation (1), R 1 Represents an alkyl group having 1 to 6 carbon atoms, optionally substituted with one or more halogen atoms; a cycloalkyl group having 3 to 6 carbon atoms, optionally substituted with one or more halogen atoms; or an aryl or heteroaryl group, optionally substituted with one or more identical or different substituents selected from halogen atoms and amino groups; R 2 Represents a hydrogen atom, an alkyl group having 1 to 3 carbon atoms, or a pharmaceutically acceptable cation; R 3 Represents a hydrogen atom, halogen atom, hydroxyl group, amino group, or alkyl group having 1 to 3 carbon atoms; R 4 Represents a hydrogen atom or a halogen atom; R 5 Represents a fluorine atom; R 6 Represents a hydrogen atom or a fluorine atom; and A represents a nitrogen atom or =CX (where X represents a hydrogen atom, a halogen atom, an amino group, a cyano group, or an alkyl group having 1 to 3 carbon atoms optionally substituted with one or more halogen atoms, or an alkoxy group having 1 to 3 carbon atoms optionally substituted with one or more halogen atoms).

[0006] Additionally, Patent Document 1 discloses 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid as one of the quinolone carboxylic acid derivatives described above. Furthermore, its hydrochloride salt is disclosed in Patent Document 2.

[0007] Another example of respiratory infection is aspiration pneumonia. Aspiration pneumonia accounts for a large proportion of pneumonia in the elderly and is a serious, refractory, recurrent, and highly fatal disease (Non-Patent Literature 1). Pathogens of aspiration pneumonia include anaerobic bacteria and Staphylococcus aureus (…). Staphylococcus aureus While anaerobic bacteria (Non-Patent Literature 1) are a major target for aspiration pneumonia, no effective treatment for it has yet been established. Currently available quinolone formulations include levofloxacin, ciprofloxacin, pazufloxacin, moxifloxacin, sitafloxacin, and canofloxacin. For aspiration pneumonia (a highly serious condition), most initial treatments use injectable formulations; however, among the aforementioned quinolone formulations, levofloxacin, ciprofloxacin, and pazufloxacin, which are available in injectable form, have insufficient antibacterial activity against anaerobic bacteria and are not recommended for use in patients suspected of having aspiration pneumonia (Non-Patent Literature 2). Among oral formulations, sitafloxacin, moxifloxacin, and canofloxacin may be effective against anaerobic bacterial infections (Non-Patent Literature 3-5), but there are no published papers providing strong evidence against aspiration pneumonia, and no effective treatment has yet been established.

[0008] Similar to aspiration pneumonia, examples of respiratory infections primarily caused by anaerobic bacteria include lung abscess (Non-Patent Literature 6). Although there are reports of observed therapeutic efficacy for moxifloxacin and pazufloxacin (Non-Patent Literature 3-4 and Non-Patent Literature 7), they have not yet been established as effective treatments.

[0009] Citation List Non-patent literature Non-patent document 1: Journal of the Japanese Society of Internal Medicine, No. 99-11, November 10, 2010, pp. 2746-2751.

[0010] Non-patent document 2: Japan Respiratory Society, "Diagnosis and Treatment of Medical and Nursing-Associated Pneumonia", page 23.

[0011] Non-patent literature 3: Infection (Munich, Germany) (2008), 36(1), 23-30.

[0012] Non-patent literature 4: Expert Review of Respiratory Medicine (2007), 1(1), 111-119.

[0013] Non-patent document 5: Japan Respiratory Society, "Diagnosis and Treatment of Pneumonia in Adults 2017", page 24.

[0014] Non-patent document 6: Journal of the Japanese Respiratory Society, 49(9): 623-628, 2011.

[0015] Non-patent literature 7: Nippon Kagaku Ryoho Gakkai Zasshi (1999), 47(Supplement 1), 196-203.

[0016] Patent documents Patent Document 1: International Publication No. WO 2005 / 026147 Patent Document 2: International Publication No. WO 2013 / 069297. Invention Overview Technical issues The purpose of this invention is to provide a novel therapeutic agent for respiratory tract infections.

[0017] Solution to the problem The inventors have investigated highly effective and safe therapeutic agents for respiratory infections. They have conducted extensive research on the aforementioned problems and discovered that 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid is extremely effective as a therapeutic agent for aspiration pneumonia, pulmonary suppuration, or lung abscess, and thus completed this invention.

[0018] The gist of this invention is as follows: [1] A treatment for aspiration pneumonia, lung suppuration or lung abscess, comprising 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable salt thereof as the active ingredient.

[0019] [2] A treatment for aspiration pneumonia, comprising 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidine-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable salt thereof as the active ingredient.

[0020] [3] A therapeutic agent for lung suppuration or lung abscess, comprising 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable salt thereof as the active ingredient.

[0021] [4] According to the therapeutic agent described in [1], the pathogen causing aspiration pneumonia, lung suppuration, or lung abscess is selected from one or more of the following bacteria: belonging to Prevotella (… Prevotella Bacteria belonging to the genus *Peptostreptococcus* (Peptostreptococcus) Peptostreptococcus Bacteria belonging to the genus Micromonas ( ) Parvimonas Bacteria of the genus *Peptone*, belonging to the family *Peptone* (… Peptoniphilus Bacteria belonging to the genus Fingoldii ( ) Finegoldia Bacteria of the genus *Clostridium* and those belonging to the genus *Clostridium* (… Fusobacterium Bacteria of the genus )

[0022] [5] According to the treatment agent described in [2], the pathogen causing aspiration pneumonia is selected from one or more of the following bacteria: belonging to Prevotella (… Prevotella Bacteria belonging to the genus *Peptostreptococcus* (Peptostreptococcus) Peptostreptococcus Bacteria belonging to the genus Micromonas ( ) Parvimonas Bacteria of the genus *Peptone*, belonging to the family *Peptone* (… Peptoniphilus Bacteria belonging to the genus Fingoldii ( ) Finegoldia Bacteria of the genus *Clostridium* and those belonging to the genus *Clostridium* (… Fusobacterium Bacteria of the genus )

[0023] [6] According to the therapeutic agent described in [3], the pathogen causing the lung suppuration or lung abscess is selected from one or more of the following bacteria: belonging to Prevotella (… Prevotella Bacteria belonging to the genus *Peptostreptococcus* (Peptostreptococcus) Peptostreptococcus Bacteria belonging to the genus Micromonas ( ) Parvimonas Bacteria of the genus *Peptone*, belonging to the family *Peptone* (… Peptoniphilus Bacteria belonging to the genus Fingoldii ( ) Finegoldia Bacteria of the genus *Clostridium* and those belonging to the genus *Clostridium* (… Fusobacterium Bacteria of the genus )

[0024] [7] According to the therapeutic agent described in [1], the pathogen causing aspiration pneumonia, lung suppuration, or lung abscess is selected from one or more of the following bacteria: belonging to Bacteroides ( Bacteroides Bacteria of the genus *Prevotella* ( ) Prevotella Bacteria belonging to the genus *Porphyromonas* (…). Porphyromonas Bacteria belonging to the genus *Fusobacterium* (…). Fusobacterium Bacteria belonging to the genus *Pycnomycetes*, and belonging to the genus *Pycno Leptotrichia Bacteria belonging to the genus *Peptostreptococcus* (Peptostreptococcus) Peptostreptococcus Bacteria belonging to the genus Micromonas ( ) Parvimonas Bacteria belonging to the genus Veillonella (Veillonella) Veillonella Bacteria belonging to the genus Tylenol (Tylenol) Tissierella Bacteria of the genus *Streptococcus*, pharyngeal streptococcus ( Streptococcus anginosus ) group, and belonging to actinomycetes ( Actinomyces Bacteria of the genus )

[0025] [8] According to the treatment agent described in [2], the pathogen causing aspiration pneumonia is selected from one or more of the following bacteria: belonging to Bacteroides ( Bacteroides Bacteria of the genus *Prevotella* ( ) Prevotella Bacteria belonging to the genus Micromonas ( ) Parvimonas Bacteria belonging to the genus Veillonella (Veillonella) Veillonella Bacteria belonging to the genus *Actinomycetes* and those belonging to the genus *Actinomycetes* Actinomyces Bacteria of the genus )

[0026] [9] According to the therapeutic agent described in [3], the pathogen causing lung suppuration or lung abscess is selected from one or more of the following bacteria: belonging to Bacteroides ( Bacteroides Bacteria of the genus *Prevotella* ( ) Prevotella Bacteria belonging to the genus *Porphyromonas* (…). Porphyromonas Bacteria belonging to the genus *Fusobacterium* (…). Fusobacterium Bacteria belonging to the genus *Pycnomycetes*, and belonging to the genus *Pycno Leptotrichia Bacteria belonging to the genus *Peptostreptococcus* (Peptostreptococcus) Peptostreptococcus Bacteria belonging to the genus Micromonas ( ) Parvimonas Bacteria belonging to the genus Veillonella (Veillonella) Veillonella Bacteria belonging to the genus Tylenol (Tylenol) Tissierella Bacteria of the genus *Streptococcus* and pharyngeal streptococci ( Streptococcus anginosus )group.

[0027]

[10] According to the therapeutic agent described in [1], wherein the daily dose of 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable salt thereof, converted to 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable salt thereof is 300 mg on the first day of administration and 150 mg on the second day and thereafter.

[0028]

[11] According to the therapeutic agent described in [2], wherein the daily dose of 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable salt thereof, converted to 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable salt thereof is 300 mg on the first day of administration and 150 mg on the second day and thereafter.

[0029]

[12] According to the therapeutic agent described in [3], wherein the daily dose of 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable salt thereof, converted to 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable salt thereof is 300 mg on the first day of administration and 150 mg on the second day and thereafter.

[0030] Advantages of the invention According to the present invention, a therapeutic agent for aspiration pneumonia, pulmonary suppuration, or pulmonary abscess may be provided, comprising administering to a patient 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable salt thereof.

[0031] Description of the implementation plan The following describes one embodiment of the present invention in detail.

[0032] The therapeutic agents of this embodiment relate to therapeutic agents for respiratory diseases, particularly those for respiratory infections. More specifically, the therapeutic agents of this embodiment relate to therapeutic agents for aspiration pneumonia, pulmonary suppuration, or lung abscess, comprising administering 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidine-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable salt thereof to a patient, including a human.

[0033] Respiratory tract infection refers to infection occurring in any part of the respiratory tract. In addition, the respiratory tract is a general term for the organs related to breathing, and refers to the organs from the nasal vestibule through the nasal cavity, pharynx, larynx, trachea, bronchi and bronchioles to the alveoli.

[0034] In this article, "aspiration pneumonia" is a respiratory condition involving swelling and infection of the lungs and airways, and is believed to be caused by inhaling harmful substances. Patients with aspiration pneumonia may experience symptoms such as coughing and difficulty breathing.

[0035] In this article, patients with aspiration pneumonia are defined as those who meet the following criteria: • A clear, acutely appearing infiltrative shadow is observed on chest X-ray or CT images. • Clearly confirmed inhalation, confirmed recurrent air obstruction, confirmed functional impairment in swallowing function assessment tests, or the patient has a medical complication or history of possible swallowing difficulties. • The patient exhibits characteristic symptoms and inflammation of aspiration pneumonia.

[0036] Examples of characteristic symptoms and inflammation of aspiration pneumonia include cough, purulent sputum, moist rales, dyspnea, fever, positive CRP, leukocytosis, and hypoxemia.

[0037] In this article, "pulmonary suppuration" refers to necrotizing lung infection, also known as lung abscess, and is believed to be caused by bacteria from the mouth and throat being aspirated into the lungs. Patients with pulmonary suppuration may experience symptoms such as fatigue, loss of appetite, night sweats, fever, weight loss, and a cough with phlegm.

[0038] In this article, patients with pulmonary abscess are defined as those who meet the following criteria: • A mass-like shadow or a shadow with internal cavitation (nodular shadow, mass shadow) observed on chest X-ray or CT images. (This is unrelated to the presence or absence of an air-fluid level (niveau) attributed to pus accumulation.) • The patient presents with characteristic symptoms and inflammation of pulmonary suppuration / pulmonary abscess.

[0039] Examples of characteristic symptoms and inflammation of lung suppuration or lung abscess include cough, purulent sputum, moist rales, dyspnea, fever, positive CRP, leukocytosis, and hypoxemia.

[0040] Finding safe and effective compounds against anaerobic pathogens is important for the effective treatment of diseases such as aspiration pneumonia, pulmonary suppuration, or lung abscess. The applicant has discovered that, unlike other quinolone compounds, 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid and its pharmaceutically acceptable salts are effective against anaerobic pathogens. For example, injectable formulations of quinolone compounds such as levofloxacin, ciprofloxacin, or pazufloxacin are considered unsuitable as treatments for aspiration pneumonia (Non-Patent Literature 2).

[0041] However, the applicant has discovered that 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidine-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid and its pharmaceutically acceptable salts are effective against anaerobic pathogens and are effective in treating aspiration pneumonia.

[0042] 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4- can be prepared, for example, according to the method described in Patent Document 1 or 2. Fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable salt thereof.

[0043] Obligate anaerobes that cause aspiration pneumonia, lung suppuration, or lung abscess include those belonging to the Bacteroides family (…). Bacteroides Bacteria of the genus *Prevotella* ( ) Prevotella Bacteria belonging to the genus *Porphyromonas* (…). Porphyromonas Bacteria belonging to the genus *Fusobacterium* (…). Fusobacterium Bacteria belonging to the genus *Pycnomycetes*, and belonging to the genus *Pycno Leptotrichia Bacteria belonging to the genus *Peptostreptococcus* (Peptostreptococcus) Peptostreptococcus Bacteria belonging to the genus Micromonas ( ) Parvimonas Bacteria belonging to the genus Veillonella (Veillonella) Veillonella Bacteria belonging to the genus Tylenol (Tylenol) Tissierella Bacteria of the genus *Peptone*, belonging to the family *Peptone* (… Peptoniphilus Bacteria belonging to the genus *Fingoldii* and *Fingoldii* ( Finegoldia Bacteria of the genus *Streptococcus*, and facultative anaerobes including *Streptococcus pharyngitis*. Streptococcus anginosus Group (which includes Streptococcus) Streptococcus ) genus) and belong to actinomycetes ( Actinomyces 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid exhibits high antibacterial activity against the anaerobic bacteria described above, and also shows high therapeutic efficacy against aspiration pneumonia, lung suppuration, or lung abscess.

[0044] Examples of pathogens causing aspiration pneumonia include those belonging to the Prevotella family (…). Prevotella Bacteria belonging to the genus *Peptostreptococcus* (Peptostreptococcus) Peptostreptococcus Bacteria belonging to the genus Micromonas ( ) Parvimonas Bacteria of the genus *Peptone*, belonging to the family *Peptone* (… Peptoniphilus Bacteria belonging to the genus Fingoldii ( ) Finegoldia Bacteria belonging to the genus *Fusobacterium* (…). Fusobacterium Bacteria of the genus *Bacteroides*, belonging to the genus *Bacteroides*. Bacteroides Bacteria belonging to the genus *Streptococcus* and those belonging to the genus *Streptococcus* Streptococcus Bacteria of the genus .

[0045] Regarding the treatment of aspiration pneumonia, especially when the causative agent is Bacteroides, 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidine-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid exhibits high therapeutic efficacy. Bacteroides Bacteria of the genus *Prevotella* ( ) Prevotella Bacteria belonging to the genus Micromonas ( ) Parvimonas Bacteria belonging to the genus Veillonella (Veillonella) Veillonella Bacteria belonging to the genus ) or Actinomycetes ( Actinomyces Bacteria of the genus )

[0046] Examples of pathogens causing lung suppuration or lung abscess include those belonging to the Prevotella family (…). Prevotella Bacteria belonging to the genus *Peptostreptococcus* (Peptostreptococcus) Peptostreptococcus Bacteria belonging to the genus Micromonas ( ) Parvimonas Bacteria of the genus *Peptone*, belonging to the family *Peptone* (… Peptoniphilus Bacteria belonging to the genus Fingoldii ( ) Finegoldia Bacteria belonging to the genus *Fusobacterium* (…). Fusobacterium Bacteria of the genus *Bacteroides*, belonging to the genus *Bacteroides*. Bacteroides Bacteria belonging to the genus *Streptococcus* and those belonging to the genus *Streptococcus* Streptococcus Bacteria of the genus .

[0047] Regarding the treatment of lung suppuration or lung abscess, especially when the causative agent is *Prevotella*, 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid exhibits high therapeutic efficacy. Prevotella Bacteria belonging to the genus *Porphyromonas* (…). Porphyromonas Bacteria belonging to the genus *Fusobacterium* (…). Fusobacterium Bacteria belonging to the genus *Pycnomycetes*, and belonging to the genus *Pycno Leptotrichia Bacteria belonging to the genus *Peptostreptococcus* (Peptostreptococcus) Peptostreptococcus Bacteria belonging to the genus Micromonas ( ) Parvimonas Bacteria belonging to the genus Veillonella (Veillonella) Veillonella Bacteria belonging to the genus Tylenol (Tylenol) Tissierella Bacteria of the genus *Streptococcus* or pharyngeal streptococci (Streptococcus anginosus) group.

[0048] Belongs to Prevotella ( Prevotella Examples of bacteria in the genus *Prevotella spp.* include *Prevotella spp.* P. denticola ), Prevotella loperae ( P. loescheii ), melanin-producing Prevotella ( P. melaninogenica ), Prevotella intermedia ( P. intermedia Prevotella melanogaster ( ) P. nigrescens ), Prevotella pallida ( P. pallens ), Prevotella buccali ( P. buccae ), Prevotella oris ( Grams of mouth ), buccal prevostii ( P. buccalis ), oral prevostii ( P. oral ), Prevotella divaricata ( P. bivia ), Prevotella glycopeptone ( P. dissing ), Prevotella pleurisy P. pleurisy Bergen Prevotella ( P. bergensis ), Timon Prevotella ( P. timonensis )or P. finances From the viewpoint of the therapeutic efficacy of 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid, it is more preferable to mention that the causative agent of aspiration pneumonia is *Prevotella melanin-producing*. P. melaninogenica ), Prevotella intermedia ( P. intermedia ) or Prevotella buccali ( P. buccae The condition and the pathogen causing lung suppuration or lung abscess are Prevotella melanin-producing bacteria. P. melaninogenica), Prevotella intermedia ( P. intermedia ) or oral Prevotella ( Oral tablet (The situation is as follows.)

[0049] Belongs to Peptostreptococcus ( Peptostreptococcus Examples of bacteria in the genus *Streptococcus* include anaerobic digestive streptococci (…). P. anaerobic ) and Peptostreptococcus stomatitis ( P. stomatis ).

[0050] Belongs to micromonads ( Parvimonas Examples of bacteria in the genus *Micromonas* include *Micromonas microphylla*. P. micra From the viewpoint of the therapeutic efficacy of 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid, it is more preferable to mention that the pathogens causing aspiration pneumonia, lung suppuration, or lung abscess are Micromonas microbes (…). P. micra (The situation is as follows.)

[0051] Belongs to peptone bacteria ( Peptoniphilus Examples of bacteria in the genus *Peptospira* include *Peptospira saccharitroph*. Peptoniphilus asaccharolytic ), Effervescentis ( Ivory-billed Peptoniphilus ) 、 Lacrimal gland peptone ( Peptoniphilus lacrimal ) and Peptone ( Peptoniphilus harei From the viewpoint of the therapeutic efficacy of 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid, it is more preferable to mention *Peptospira spp.* as the causative agent of aspiration pneumonia, pulmonary suppuration, or pulmonary abscess. Peptoniphilus asaccharolyticus (The situation is as follows.)

[0052] Belongs to Fingold bacteria ( Finegoldia Examples of bacteria in the genus *Goldobacter* include *Granifera macrophylla*. Finegoldia great From the viewpoint of the therapeutic efficacy of 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid, it is more preferable to mention that the causative agent of aspiration pneumonia, lung suppuration, or lung abscess is *Goldobacter griseus*. Finegoldia magna (The situation is as follows.)

[0053] Belongs to Fusobacterium ( Fusobacterium Examples of bacteria in the genus *Clostridium necrophorum* include *Clostridium necrophorum*. F. necrophorus ), Fusobacterium nucleatum ( F. nucleatum ), Clostridium difficile ( F. deadly ) and Fusobacterium proteus ( F. various From the viewpoint of the therapeutic efficacy of 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid, it is more preferable to mention that the pathogen causing lung suppuration or lung abscess is Fusobacterium nucleatum (…). F. nucleatum ) or Clostridium necrophorum ( F. necrophorum (The situation is as follows.)

[0054] Belongs to Bacteroides ( Bacteroides Examples of bacteria in the genus *Bacteroides fragilis* include *Bacteroides fragilis*. B. fragilis ), Bacteroides multiforme ( B. thetaiotaomicron ), Bacteroides commonis ( B. vulgaris ), Bacteroides ovalis ( B. ovatus ), Bacteroides monomorpha ( B. uniformis Bacteroides emblica ( B. eggerthii ), B. nordii , B. salyeresae and Bacteroides masei ( B. massiliensis From the viewpoint of the therapeutic efficacy of 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid, it is more preferable to mention that the pathogen causing lung suppuration or lung abscess is Bacteroides fragilis (…). B. fragilis (The situation is as follows.)

[0055] Belongs to Porphyromonas ( Porphyromonas Examples of bacteria in the genus *Porphyromonas gingivalis* include *Porphyromonas gingivalis*. P. gingival ), Porphyromonas pulpis ( P. endodontalis ), Porphyromonas unsaturates ( P. asaccharolytic ), Porphyromonas leucis ( P. levii )and P. venonis From the viewpoint of the therapeutic efficacy of 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid, it is more preferable to mention that the pathogen causing lung suppuration or lung abscess is *Porphyromonas gingivalis* (…). P. gum ) or Porphyromonas pulpis ( P. endodontalis (The situation is as follows.)

[0056] Belongs to the filiform bacteria ( LeptotrichiaExamples of bacteria in the genus *Trichophyton* include oral ciliates (…). L. buccalis Herba Herba var. hupensis ( L. hofstadii ), Hong Kong Ciliobacterium ( L. hongkongensis ), Salmonella ciliates ( L. shahii ), Goodfellow Ciliates ( L. goodfellowii ) 、 Trichophyton tergentii ( L. trevisanii ) and Wedgrenella ( L. wade From the viewpoint of the therapeutic efficacy of 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid, it is more preferable to mention that the pathogen causing lung suppuration or lung abscess is *Trichophyton mentagrophytes* (oral fibrillary bacteria). L. buccalis (The situation is as follows.)

[0057] Belongs to Veillonella ( Veillonella Examples of bacteria in the genus *Veillonella* include *Veillonella*. V. little girl Atypical Veillonella ( V. atypical )and V. montpelliensis .

[0058] Belongs to Tylenol ( Tissierella Examples of bacteria in the genus *C.* include *C. creatinine* (*C. lysinus* T. creatinini ) 、 Creatinoides ( T. creatinophila ) and Typhimurium ( T. preacuta From the viewpoint of the therapeutic efficacy of 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid, it is more preferable to mention that the pathogen causing lung suppuration or lung abscess is *C. creatinine* (…). T. creatine (The situation is as follows.)

[0059] Belongs to the pharyngeal streptococcus ( Streptococcus anginosus Examples of bacteria in the group include Streptococcus intermediate (…). S. intermedius ) and Streptococcus constellans ( S. constellatus From the viewpoint of the therapeutic efficacy of 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid, it is more preferable to mention that the pathogen causing lung suppuration or lung abscess is *Streptococcus intermedius* (…). S. intermediate ) and Streptococcus constellans ( S. constellatus (The situation is as follows.)

[0060] Belongs to actinomycetes ( Actinomyces Examples of bacteria in the genus *Actinomyces* include *European Actinobacterium*. A. europaeus ), Georg actinomycetes ( A. georgiae ), Actinomyces glossii ( A. gerencseriae ), Grafeniz Actinomycetes ( A. Graevenitzii ), Actinomyces ylangis ( A. israelii ), Meiss's Actinomycetes ( A. meyerii ), Actinomyces nipponense ( A. naeslundii ), Newton's Actinomycetes ( A. neuii Dental caries actinomycetes ( A. odontolyticus ), root actinomycetes ( A. to root s), Actinomyces radiensis ( A. radingae ), Tuletz Actinomycetes ( A. turicensis ), Urogenital Actinomyces ( Urogenital artery ), sticky actinomycetes ( A. viscosus ) and Actinomycetes ( Actinomyces From the viewpoint of the therapeutic efficacy of 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid, it is more preferable to mention that the pathogen causing aspiration pneumonia is *Actinomyces dentalis* (sp.). A. odontolyticus (The situation is as follows.)

[0061] In this article, the concept of pathogenic bacteria also includes bacteria that have acquired drug resistance. Drug resistance refers to the phenomenon in which an organism becomes resistant to a drug, rendering the drug ineffective or less effective. Examples of drug resistance include resistance to penicillin, cephalosporins, carbapenem, aminoglycosides, macrolides, lincomycin, trimethoprim-sulfamethoxazole, tetracycline, metronidazole, glycopeptides, oxazolidinones, daptomycin, and quinolones.

[0062] Examples of pharmaceutically acceptable additives contained in the above-mentioned pharmaceutical compositions together with 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid include excipients, lubricants, binders, disintegrants, stabilizers, flavoring agents, and diluents. These additives are not particularly limited, provided they are suitable for the preparation of pharmaceutical formulations, and where appropriate, additives such as those described in the "Encyclopedia of Pharmaceutical Additives" (Japan Pharmaceutical Additives Association, Pharmaceutical Daily (2007)) may be used.

[0063] The therapeutic agent of this embodiment is administered to a subject, such as a human, using conventional pharmaceutically well-known forms and routes of administration. For example, it can be administered orally or parenterally in formulations such as powders, tablets, capsules, fine granules, granules, syrups, injections, ophthalmic solutions, aqueous nasal drops, aqueous ear drops, or inhalation solutions. That is, the therapeutic agent of this embodiment can be prepared by mixing the active ingredient with physiologically acceptable carriers, excipients, binders, and diluents, for example, in the dosage forms exemplified above.

[0064] In the therapeutic agents of this embodiment, for the purposes of reducing side effects, preparing easily administered small formulations, and preventing the emergence of drug-resistant bacteria, the minimum daily dose of 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable salt thereof preferably includes 10 mg or more, 20 mg or more, 50 mg or more, 100 mg or more, 125 mg or more, and 150 mg or more. Furthermore, the maximum daily dose preferably includes 300 mg or less, 250 mg or less, 200 mg or less, and 175 mg or less. Examples of daily doses of 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable salt thereof include 10 mg or more and 300 mg or less, more preferably 20 mg or more and 250 mg or less, further preferably 50 mg or more and 200 mg or less, further preferably 100 mg or more and 200 mg or less, further preferably 125 mg or more and 175 mg or less, and particularly preferably 150 mg. In cases where a pharmaceutically acceptable salt of 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid is used, the value converted to the free form is used as the above-mentioned daily dose. The daily dose may be administered once or divided into 2 to 3 doses, but once daily is preferred. Alternatively, if the effect is insufficient, a dose twice the daily dose may be used.

[0065] Furthermore, loading dosing is preferred to rapidly achieve the target blood concentration. Loading dosing refers to a dosing design that achieves the target blood concentration in an early stage by increasing the daily dose or the number of daily doses during the initial phase of dosing. The initial phase of dosing refers to days 1 to 3 of starting dosing, preferably days 1 to 2, and more preferably day 1. Additionally, as an increase in the daily dose, it is preferable to use twice the daily dose.

[0066] In cases of loading dosing, it is preferable to use twice the daily dose on the first day of dosing. A more preferred daily dose, converted to free form, for 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable salt thereof, is 300 mg on the first day of dosing and 150 mg on the second day and thereafter.

[0067] The preferred dosage of 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride is 300 mg on the first day of administration and 150 mg on the second day and thereafter. Here, the dosage is expressed as a value obtained by converting 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride to its free form.

[0068] Pharmaceutically acceptable salts may be used in the form of pharmaceutically acceptable salts of 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid. Examples of pharmaceutically acceptable salts include salts of inorganic acids, such as hydrochloric acid, hydrobromic acid, sulfuric acid, and phosphoric acid; salts of organic acids, such as maleic acid, fumaric acid, succinic acid, malic acid, malonic acid, methanesulfonic acid, toluenesulfonic acid, benzenesulfonic acid, lactic acid, oxalic acid, acetic acid, trifluoroacetic acid, and tartaric acid; or salts of metals, such as sodium, potassium, magnesium, calcium, aluminum, cesium, chromium, cobalt, copper, iron, zinc, platinum, and silver. Among these, hydrochloride salts are particularly preferred.

[0069] "Free form" refers to 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid, which is neither a salt, co-crystallization, nor hydrate, and has C 21 H 24 A compound with the molecular formula F3N3O4 and a molecular weight of 439.44.

[0070] The therapeutic agent of this embodiment may consist solely of 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable salt thereof as the active ingredient. Alternatively, the therapeutic agent of this embodiment may be configured as a pharmaceutical composition containing 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable salt thereof, and other compounds and / or pharmaceutically acceptable additives acting as the active ingredient.

[0071] The pharmaceutical composition may contain one or more compounds as other compounds serving as active ingredients and / or pharmaceutically acceptable additives. For example, the pharmaceutical composition is prepared by mixing 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable salt thereof with one or more of other compounds serving as active ingredients and additives.

[0072] As described above, according to this embodiment, a technology relating to a therapeutic agent can be provided that exhibits high therapeutic efficacy and safety against aspiration pneumonia, pulmonary suppuration, or pulmonary abscess. By using appropriate compositions as described herein, adequate therapeutic effects can be achieved even at low doses, while reducing side effects and the frequency of drug-resistant bacterial development.

[0073] (Example) The invention will be described in more detail below by way of illustrated embodiments, but the scope of the invention is not limited to these embodiments. Limitations of the implementation rules.

[0074] A 150 mg injection of 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid (hereinafter also referred to as Investigational New Drug A) was prepared according to the method disclosed in International Publication No. WO 2016 / 195014.

[0075] The "150 mg" in the 150 mg injection indicates the weight of 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride converted to its free form. In preparing the injection, 162.5 mg (converted to free form: 150 mg) of 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride was used. (Example 1) Aspiration pneumonia Thirteen subjects suspected of having aspiration pneumonia who met the following criteria were given an intravenous dose of the investigational new drug A for 7–14 days. • Individuals aged 16 years or older with acute, well-defined infiltrative shadows observed on chest X-ray or CT images taken within 48 hours prior to the start of administration. • Identify clear signs of inhalation, airway obstruction, or dysphagia, and have a history or condition that suggests dysphagia. • The patient exhibits characteristic symptoms and inflammation of aspiration pneumonia.

[0076] On the first day of dosing, administer two doses of Investigational New Drug A (300 mg / day), and on the second day, administer one dose of Investigational New Drug A (150 mg / day), then maintain the same dose (150 mg / day). Each dose is administered intravenously over approximately 1 hour.

[0077] (Experimental Example 2) Lung suppuration or lung abscess Eleven subjects suspected of having pulmonary suppuration or pulmonary abscess who met the following criteria were given the investigational new drug A intravenously for 7–14 days. • Individuals aged 16 years or older whose chest X-ray or CT scan shows a mass-like shadow or shadow with internal cavitation (nodular shadow, mass shadow) within 48 hours prior to the start of administration. This is unrelated to the presence or absence of an air-fluid level (niveau) attributable to pus accumulation. • The patient presents with characteristic symptoms and inflammation of lung suppuration or lung abscess.

[0078] On the first day of dosing, administer two doses of Investigational New Drug A (300 mg / day), and on the second day, administer one dose of Investigational New Drug A (150 mg / day), then maintain the same dose (150 mg / day). Each dose is administered intravenously over approximately 1 hour.

[0079] Based on the criteria for clinical efficacy against pneumonia described in the New Regulations for Antibacterial Drugs for Respiratory Infections (Second Edition) (Nikkei Journal of the Japan Chemical Society 2012; 60(1): 30-45. 9), the following criteria were established to determine the clinical efficacy of Case 1 and Case 2. The primary evaluation item was the efficacy rate of the investigational new drug A at the end or discontinuation of administration.

[0080] In this article, "end of dosing" refers to the evaluation date the day following the completion date of dosing of the investigational new drug A. "Discontinuation" refers to the evaluation date implemented within 3 days from the last dosing date of the investigational new drug A or the date of discontinuation. Furthermore, "end of dosing or discontinuation" is expressed as "end of treatment (EOT)". Additionally, CRP is short for C-reactive protein and is one of the acute-phase reactants produced in a short period of time in response to various inflammations. It is a useful indicator for observing treatment efficacy because it rises within hours in bacterial infections such as pneumonia and rapidly decreases as inflammation subsides.

[0081] • Early drug efficacy assessment and at the end of treatment (EOT) Three days after administration, according to Table 1, the early drug efficacy assessment was determined in three levels: "early therapeutic effect", "no early therapeutic effect" and "cannot be determined".

[0082] "Early therapeutic effect" is defined as cases in which significant improvement is observed 3 days after administration (regardless of whether administration is completed or continued after 4 days). Additionally, in cases where CRP levels and chest X-rays do not improve 3 days after administration compared to before administration, even if there is no change or worsening of CRP or chest X-ray findings, improvement in clinical symptoms and body temperature is considered an "early therapeutic effect."

[0083] If CRP or chest X-ray findings remain unchanged or worsen, and clinical symptoms and body temperature do not change or improve, the study is deemed "no early treatment response." Taking full account of the participants' safety, investigators and other relevant personnel make appropriate decisions, such as discontinuing the clinical trial and switching to other antibiotics. Samples for microbiological evaluation should be collected before initiating appropriate alternative antibiotic therapy.

[0084] Furthermore, if the discontinuation date is the start date of administration (day 0) or the second day of administration (day 1), it is considered unnecessary to determine the efficacy of the drug in the early stages. In cases where administration begins on the third day (day 2) or later, the test results at the time of discontinuation should be used for determination.

[0085] For the end of treatment (EOT), clinical efficacy at the end of administration or at the time of discontinuation is determined according to Table 1 in three levels: "effective", "ineffective", and "indeterminate". In cases where treatment is discontinued after the day following the end of administration, clinical efficacy at the end of administration is determined, but clinical efficacy at the time of discontinuation does not need to be determined.

[0086] Furthermore, treatment is deemed "ineffective" in cases of discontinuation of treatment or when an investigational new drug is switched to an alternative antibiotic after its administration is completed. However, this does not apply to cases where the treatment was deemed "effective" according to the criteria in Table 1 at the end of treatment (EOT), even if the treatment is switched to an alternative antibiotic. In cases of switching to an alternative antibiotic, in principle, prescribed tests, examinations, and assessments at the end of treatment should be conducted before the switch.

[0087] [Table 1] Tables 2 and 3 show the results of early drug efficacy assessments and the end of treatment in Case 1 and Case 2.

[0088] [Table 2] .

[0089] [Table 3] .

[0090] The efficiency is a value obtained by the following formula. Effectiveness = (Number of objects rated as "effective" ÷ Number of objects rated as "effective" or "ineffective") × 100 (%).

[0091] Tables 2 and 3 show that 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable salt thereof has a high therapeutic effect on aspiration pneumonia, pulmonary suppuration, or lung abscess. In particular, the efficacy rate at the end of treatment was significantly high, reaching 100% for aspiration pneumonia and 91% for pulmonary suppuration or lung abscess.

[0092] Tables 4 and 5 show the microbiological efficacy of the pathogens in Test Case 1 and Test Case 2.

[0093] [Table 4]

[0094] [Table 5]

[0095] Tables 4 and 5 show that 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidone-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable salt thereof has a high antibacterial effect against pathogens causing aspiration pneumonia, pulmonary suppuration, or lung abscess.

[0096] Industrial applicability According to this implementation plan, it is possible to provide a treatment for aspiration pneumonia, lung suppuration, or lung abscess, which is industrially useful.

Claims

1. A treatment agent for aspiration pneumonia, pulmonary suppuration or pulmonary abscess, comprising 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidine-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable salt thereof as the active ingredient.

2. A treatment agent for aspiration pneumonia, comprising 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidine-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable salt thereof as the active ingredient.

3. A therapeutic agent for lung suppuration or lung abscess, comprising 7-[(3S,4S)-3-{(cyclopropylamino)methyl}-4-fluoropyrrolidine-1-yl]-6-fluoro-1-(2-fluoroethyl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable salt thereof as the active ingredient.

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